Main objectives of the study are the effect of administration of low dose colchicine on the incidence of atrial fibrillation, ICU (Intensive Care Unit) stay and hospital stay following coronary bypass surgery in the intervention and control groups. It is told to the patients that they may take colchicine or placebo in the informed consent. Therefore, patients are not aware of their therapeutic group. The patients and medical personnel are not aware of the type of tablets in the boxes (colchicine or placebo). Only the researcher is aware of the code written on the boxes of the tablets; so, this study is a double-blind, parallel clinical trial. Inclusion criteria include patients with coronary artery disease (on angiography). Exclusion criteria are patients above 80 years old, patients with heart valve disease or arrhythmia, history of using anti-arrhythmic drugs or pacemaker. Two hundred-sixteen patients using random numbers (created by computer) are divided into intervention and control groups. Thus, 108 cases in each treatment arm are randomized to receive placebo or colchicine. In the intervention group, a total of 7.0 mg oral colchicine is administered as: 1.0 mg, the night before surgery and also 1.0 mg, on the morning of surgery and then from the first day after operation followed by a maintenance dose of 0.5 mg twice a day for five days after surgery. Patients in the control group receive placebo (ineffective pill with similar size to colchicine). In this study, the main outcome variable is the atrial fibrillation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201208043799N5
Registration date:2013-01-27, 1391/11/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-01-27, 1391/11/08
Registrant information
Name
Nasim Shayan
Name of organization / entity
Cardiac Transplantation Research Center (CTRC)
Country
Iran (Islamic Republic of)
Phone
+98 21 8863 3037
Email address
ctrc@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Cardiac Surgery and Transplantation Research Center of Dr. Shariati Hospital
Expected recruitment start date
2012-10-22, 1391/08/01
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of low dose colchicin in prevention of atrial fibrillation after coronary artery bypass graft (A Placebo-Controlled Randomized Clinical Trial)
Public title
colchicin and prevention of atrial fibrillation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients with coronary artery disease (on angiography) who are candidate for coronary artery bypass. Exclusion criteria: 1- Patients above 80 years old. 2- Patients who have atrial fibrillation before surgery. 3- Patients with heart valve disease or arrhythmia or having every degree of heart block conduction. 4- Patients who use a pacemaker. 5- Patients who have chronic lung, liver or kidney disease. 6- Patients who have other heart surgeries simultaneously with bypass surgery. 7- Patients who are allergic to colchicine or in any way giving colchicine to them is contraindicated. 8- Having sick sinus syndrome.
Age
From 40 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
216
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Tehran University of Medical Sciences
Street address
Central Organization of Tehran University of Medical Sciences, Qods St., Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2012-10-10, 1391/07/19
Ethics committee reference number
91-02-94-18575-66903
Health conditions studied
1
Description of health condition studied
Coronary artery disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
AF rhythm
Timepoint
Continuous monitoring for the first 72 hours after CABG surgery and then daily ECG
Method of measurement
ECG recording device
2
Description
Length of stay in ICU
Timepoint
At the time of transferring to the ward
Method of measurement
Refer to the data sheet in ICU
3
Description
Duration of hospital stay
Timepoint
At discharge time
Method of measurement
Refer to the Patient file
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group with systolic blood pressure above 80 mmgh and rate of more than 60/min, a total of 7.0 mg oral Colchicine is administered as: 1.0 mg, the night before surgery and also 1.0 mg, on the morning of surgery and then from the first day after operation followed by a maintenance dose of 0.5 mg, twice a day in patients ≥70 kg and halved dose for patients <70 kg for five days after surgery. Colchicine is an anti-inflammatory medication used to prevent and ease gout attacks. Colchicine is available as oral tablets. Each scored tablet contains 1 mg Colchicine. This product is manufactured by Modava pharmaceutical company.
Category
Prevention
2
Description
Patients in the control group receive placebo pills which are specifically designed to have no real effect. They are made of an inert substance. These tablets in terms of size, shape, packaging and name are exactly similar to the colchicin tablets. Only the code written on the boxes are different from each other. Frequency and duration of using placebo pills in the control group are absolutely the same as colchicine pills in the intervention group. This product is manufactured by Modava pharmaceutical company.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Shariati Hosoital
Full name of responsible person
Nasim Shayan (Masters in management)
Street address
Dr. Shariati Hospital, North Karegar Ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences Vice chancellor for research
Full name of responsible person
Dr. Akbar Fotouhi (Research Deputy of Tehran University of Medical Sciences)
Street address
Central Organization of Tehran University of Medical Sciences, Qods St., Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences Vice chancellor for research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Cardiac Surgery and Transplantation Research Center of Dr. Shariati Hospital
Full name of responsible person
Nasim Shayan
Position
Executive director of Cardiac Surgery and Transplantation Research Center/ Masters in management
Other areas of specialty/work
Street address
Cardiac Surgery and Transplantation Research Center, Dr. Shariati Hospital, North Karegar Ave.
City
Tehran
Postal code
1411713137
Phone
+98 21 8863 3037
Fax
+98 21 8490 2512
Email
ctrc@tums.ac.ir; nsm_shayan@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Cardiac Surgery and Transplantation Research Center of Dr. Shariati Hospital
Full name of responsible person
Dr. Mahmoodreza Sarzaeem
Position
Assistant professor of heart surgery
Other areas of specialty/work
Street address
Cardiac Surgery and Transplantation Research Center, Dr. Shariati Hospital, North Karegar Ave.
City
Tehran
Postal code
1411713137
Phone
+98 21 8863 3037
Fax
+98 21 8490 2512
Email
ctrc@tums.ac.ir; sarzaeem_mr@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Cardiac Surgery and Transplantation Research Center of Dr. Shariati Hospital
Full name of responsible person
Nasim Shayan
Position
Executive director of Cardiac Surgery and Transplantation Research Center/ Masters in management
Other areas of specialty/work
Street address
Cardiac Surgery and Transplantation Research Center, Dr. Shariati Hospital, North Karegar Ave.
City
Tehran
Postal code
1411713137
Phone
+98 21 8863 3037
Fax
+98 21 8490 2512
Email
ctrc@tums.ac.ir; nsm_shayan@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)